HIV Outpatient Monitoring Evaluation Through Self-collection of Dried Blood Spots

NCT ID: NCT04979728

Last Updated: 2025-03-10

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 150 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-05-27
• Study Completion Date: 2025-12-31

Brief Summary

The goal of this observational study is to establish an operational framework for home self-collections of blood samples to be used for antiviral drug concentration measurements.

Participants will continue on their prescribed antiviral(s) for HIV treatment or prevention and followed for up to approximately 1 year. The investigators will compare drug concentrations of antivirals and relevant metabolites/anabolites in clinic-collected and self-collected blood samples.

Detailed Description

Up to 150 people receiving care at the UCH-IDGP will be enrolled in the study at a routine clinic visit where a standard of care (SOC) blood collection and/or SOC dose of LA antivirals (e.g., LA IM CAB±RPV) is planned. Once consented, demographic and clinical data will be obtained. Clinical data that will be collected from participant and medical records may include: age, sex at birth and gender identity, race, ethnicity, medication history, duration of current antiviral therapy, hematocrit, CD4+ T-cell count, HIV VL, and self-reported adherence.

The investigators will collect an extra ~5 mL of blood in EDTA by venipuncture for DBS, plasma, whole blood, and blood cells at each clinic-collection visit. At the first clinic-collection visit, participants will be given home self-collection kits and instructed to self-collect samples at various timepoints prior to their next injection (if on LA antivirals), monitored by live video-streaming or time-stamped video. The investigators will go through how to self-collect, handle, and mail the blood samples by self-collecting together in the clinic (in-person training), and participants will be asked about their medical history and medications.

Participants on PO antivirals (e.g., TFV/FTC) may only complete one clinic-collection visit (and one at-home self-collection). At home self-collections and clinic-collections may continue for participants on LA antivirals (e.g., LA IM CAB±RPV) for up to approximately 1 year. All study visits will be linked to SOC visits; there will be no additional visits to the clinic beyond what is already required for SOC:

• If continuing prescribed Q8W injections, up to 7 SOC clinic visits at (approximately) weeks 0, 8, 16, 24, 32, 40, and 48
• If initiating prescribed Q8W injections, up to 7 SOC clinic visits at (approximately) weeks 0, 4, 12, 20, 28, 36, and 44
• If continuing or initiating prescribed Q4W injections, up to 13 SOC clinic visits at (approximately) weeks 0, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48
• If continuing or initiating prescribed Q26W injections, up to 3 SOC clinic visits at (approximately) weeks 0, 26, and 52

Participants will be asked to self-collect samples at home by two or more methods (self-collection kits): fingerstick and spotting onto Whatman 903 protein saver card, and/or use of one or more self-collection devices (e.g., Tasso-M20/Tasso+, Mitra, others). After sample collection, samples/devices will be shipped back to our laboratory in their provided box(es). All samples obtained by self-collection methods/devices are approved for shipping via mail or other carriers in the US. Participants may complete up to 25 at home self-collections (approximately once biweekly for the participants followed longitudinally).

Conditions

HIV Treatment; HIV Prevention

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Oral Antivirals

Arm 1: People continuing oral (PO) antivirals for HIV treatment or prevention

At Home Self-Collections

Intervention Type: OTHER

Directly observed at home self-collection of blood samples

Q8W CAB±RPV Continuation

Arm 2: People continuing Q8W injections of CAB±RPV for HIV treatment or prevention

At Home Self-Collections

Intervention Type: OTHER

Directly observed at home self-collection of blood samples

Q8W CAB±RPV Initiation

Arm 3: People initiating Q8W injections of CAB±RPV for HIV treatment or prevention

At Home Self-Collections

Intervention Type: OTHER

Directly observed at home self-collection of blood samples

Q4W CAB±RPV Continuation/Initiation

Arm 4: People continuing or initiating Q4W injections of CAB±RPV for HIV treatment or prevention

At Home Self-Collections

Intervention Type: OTHER

Directly observed at home self-collection of blood samples

Q26W LEN Continuation/Initiation

Arm 5: People continuing or initiating Q26W injections of LEN for HIV treatment or prevention

At Home Self-Collections

Intervention Type: OTHER

Directly observed at home self-collection of blood samples

Interventions

At Home Self-Collections

Directly observed at home self-collection of blood samples

Intervention Type: OTHER

Other Intervention Names

Tasso-M20; Tasso+; Mitra; DBS by fingerstick

Eligibility Criteria

Inclusion Criteria

• ≥18 years old
• Receiving one or more antivirals for HIV treatment or prevention. This may include TFV (as TDF or TAF) and FTC (or 3TC)-based, LA (e.g., LA IM CAB±RPV Q4W or Q8W), or other antivirals (those who are transitioning to LA antivirals [e.g., LA IM CAB±RPV Q4W or Q8W] will also be eligible)
• Current patient at the UCH-IDGP clinic
• Able to comply with study procedures, including directly observed self-collection of DBS by fingerstick, Tasso-M20/Tasso+, Mitra, and/or other self-collection methods/devices, and completion of survey

Exclusion Criteria

• Inability to provide informed consent
• Unable or unwilling to comply with directly observed self-collection of DBS (e.g., unavailable or unable to use live video-streaming or time-stamped video recording technology)
• Any uncontrolled medical, social, or mental health issue(s) that, in the opinion of the investigators, could interfere with the study participation or study outcomes (e.g., current incarceration)
• Any medical condition that, in the opinion of the study team, acutely and/or transiently influences the PK of CAB±RPV, including acute kidney injury, hepatic insufficiency, significant drug-drug interactions, active hemolysis or symptomatic hemoglobinopathies, etc. (Note: Given the need for PK data in pregnancy, women who become pregnant while on LA IM CAB±RPV Q4W or Q8W will be allowed to participate in this study, if their clinical provider decides to continue this regimen.)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Allergy and Infectious Diseases (NIAID)

NIH

Sponsor Role: collaborator

University of Colorado, Denver

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Peter Anderson, PharmD

Role: PRINCIPAL_INVESTIGATOR

University of Colorado, Denver

Locations

University of Colorado Hospital (UCHealth)

Aurora, Colorado, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Ryan Coyle, MPH

Role: CONTACT

ryan.coyle@cuanschutz.edu

720-695-8020

Facility Contacts

Ryan Coyle, MPH

Role: primary

ryan.coyle@cuanschutz.edu

720-695-8020

Other Identifiers

R01AI170298

Identifier Type: NIH

Identifier Source: secondary_id

View Link

20-0382

Identifier Type: -

Identifier Source: org_study_id